Plasma, blood, blood products and medication bags are supplied by the millions to many medical facilities for transfusion on a daily basis. These bags are frozen and stored into inventory upon arrival and need to be thawed to no more than 36.6 C (97.99 F) before transfusion. Currently, these bags are not individually monitored for quality control. At best, evaluation of their contents is done off-line on sampled quantities. Thus, there are no routine procedures in place that can provide real-time information on the physiological and/or physical parameters of these stored biological substances from freezing to vein transfusion including source history, identification, demographics, time stamping, temperature, pH, conductivity, glucose, O2, CO2 levels etc. This situation is problematic because it creates opportunities for errors that can be harmful to patients.
The quality of frozen transfused materials depends on maintaining control over the thawing process. Underheating the substance may cause patients to experience hypothermia whereas overheating may cause severe damage (denaturation) to proteins and other components, thereby reducing the quality of the transfused fluid and endangering patients. With respect to plasma and glycerolized blood, current thawing devices are based on heat transfer through water bath or water bladders and are not capable of accurately detecting or monitoring the true temperature of plasma and glycerolized blood. Instead, these thawing devices can only provide thawing ambient temperature (i.e. water bath or water bladder temperature) and rely on a time dimension to ensure that the contents of the thawed bag is within the desired temperature range. Thus reproducible and consistent thawing results cannot be achieved without accurate temperature sensing of plasma, whole blood, glycerolized blood and red blood corpuscles. Consequently, there is a need for procedures that monitor the quality of drugs and biological substances during the freezing to vein transfusion life cycle.